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Not Yet Recruiting NCT07792122

Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol

Conditions: Post-Traumatic Stress Disorder, PTSD

Sex: Female
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 70
Sponsor: University Hospital, Toulouse

Location: Lapeyronie Hospital - Montpellier University Hospital Montpellier

Summary

Post-traumatic stress disorder (PTSD) develops after life-threatening events, with domestic violence and sexual assault being major risk factors. An innovative approach using traumatic memory reactivation with propranolol has shown promise in reducing PTSD symptoms. This study aims to compare the efficacy of propranolol with trauma-focused psychotherapy in women suffering from severe PTSD after violence.

Eligibility Criteria

Inclusion Criteria: * Women aged from 18 to 75 years * Having been victim of severe violence (rape, sexual assault, physical assault) Currently suffering from PTSD related to the traumatic event. The diagnosis of PTSD is made according to the DSM-5 criteria by a psychiatrist/psychologist using the CAPS-5, regardless of the traumatic event meeting criterion A of the DSM-5, with or without dissociative symptoms as described in the "With dissociative symptoms" section of the DSM-5, Immediate or delayed PTSD CAPS-5 total score ≥ 33 heart rate ≥ 55 bpm * The subject must have signed the consent form. * The subject must be enrolled in a social security program. * The participant must be able to understand and read French. * The participant agrees to comply with the contraception requirements outlined in the protocol. Exclusion Criteria: * Systolic blood pressure below 100 mm Hg. * Contraindications to the administration of propranolol: Asthma, Chronic obstructive pulmonary disease, Decompensated heart failure, Cardiogenic shock, Unpaced second-degree atrioventricular block, Unpaced third-degree atrioventricular block, Spasmodic angina, Uncompensated sinus node dysfunction, bradycardia, Raynaud's syndrome, severe peripheral circulatory disorder, untreated pheochromocytoma, arterial hypotension, hypersensitivity to beta-blockers, history of anaphylactic allergic reaction. * Heart failure (compensated or decompensated) * Severe liver disease * Significant renal impairment * Myasthenia gravis * Personal or family history of psoriasis * Patients who have suffered a head injury within the past year or who have clinical symptoms and residual neurological sequelae * Wearing contact lenses * Severe psychiatric disorders: Severe symptoms of other anxiety disorders, severe symptoms of Obsessive-Compulsive Disorder, history of or current psychotic disorder, bipolar mood disorder, severe personality disorder, alcohol or other substance use disorder * "Yes" response to item 4 of the C-SSRS: active suicidal ideation with intent to act, without a specific plan, and/or "Yes" response to item 5 of the C-SSRS: active suicidal ideation with a specific plan and intent to act * Hospitalized or treated for suicidal behavior within the past 3 months * Previous intolerance to a beta-blocker. * Women of childbearing age not using contraception. * Pregnancy, breastfeeding. * Current use of a beta-blocker, regardless of the formulation. * Known interactions with Propranolol (combination use not recommended and combinations to be used with caution) as indicated in the summary of product characteristics. * Undergoing psychotherapy or pharmacological treatment with psychotropic agents such as antidepressants, neuroleptics, and/or mood stabilizers. However, these subjects may be included after a 2-week therapeutic abstinence period (6 weeks for treatment with fluoxetine). * Patients under judicial protection, under guardianship or curatorship, individuals under family authorization, or under a future protection order with representation regarding the person * Participants who are related to a person involved in the study at the investigator's center, within the clinical research organization (CRO), or at the sponsor * Participation in another interventional research study, clinical trial, or clinical investigation within the 6 months preceding selection

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07792122). StuddyBuddy aggregates publicly available trial information.